A Prospective Feasibility Study Using ctDNA to Tailor Neoadjuvant Chemotherapy for Patients With Colorectal or Appendiceal Adenocarcinoma
M.D. Anderson Cancer Center
Summary
To learn if circulating tumor DNA (ctDNA) testing before cytoreductive surgery (CRS) with or without heated intraperitoneal chemotherapy (HIPEC) can show if patients have a low or high risk of the disease returning and help doctors decide if less or more intense chemotherapy is needed as treatment before surgery. ctDNA testing measures the amount of tumor DNA (genetic information) in the blood.
Description
Primary Objectives: • The primary aim of this prospective study is to assess and compare the recurrence-free survival following CRS and HIPEC of carcinomatosis of colorectal or appendiceal origin with curative intent among ctDNA-negative and ctDNA-positive patients based on their ctDNA status immediately prior to CRS and HIPEC Secondary Objectives: * To assess 1 and 2-year recurrence-free survival following CRS and HIPEC with curative intent among ctDNA-negative and ctDNA-positive patients * To assess and compare 2-year overall survival following CRS and HIPEC among ctDNA-negative and ctDNA…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically/cytologically confirmed diagnosis of moderate or poorly differentiated appendiceal or colorectal adenocarcinoma of any grade with Initial resectable disease. * Have metastatic peritoneal disease that is visible on imaging or at the time of laparoscopy. * Age ≥18 years. Because no adverse event data are currently available on the use of ctDNA in chemotherapy decision making in patients \<18 years of age, children are excluded from this study. * ECOG performance status ≤1 (Karnofsky ≥70%,). * Patients must have adequate organ and marrow function as defined b…
Interventions
- ProcedureCirculating tumoral DNA directed neoadjuvant therapy arm
Given by IV (vein)
Location
- M D Anderson Cancer CenterHouston, Texas